NA 02.210.114Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982052919), received between May 18, 2018 and Dec 27, 2022 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (2 reports).

9 other recalls cover devices cleared under the same FDA submission (K071184, K100776, K102694, K103243); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 27, 2022Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON DECEMBER 5, 2022,THE PROVIDER ATTEMPTED TO PLACE THE SCREW AFTER DRILLING AND IT WOULD NOT EASILY SCREW IN. HE SAID THE SCREW APPEARED "DULL". THEY TRIED A NEW SCREW AFTER AND WERE ABLE TO PLACE WITHOUT DIFFICULTY. NO HARM WAS DONE TO THE PATIENT. THIS REPORT IS FOR ONE (1) 2.4MM VA LOCKING SCREW SDDRIVE 14MM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16052400 ↗
• InjuryMay 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE SURGEON WAS REMOVING 2.4MM VA-LCP TWO-COLUMN VOLAR DISTAL RADIUS PLATE BECAUSE THE PATIENT HAD TENDON IRRITATION. EVERYTHING WAS REMOVED SUCCESSFULLY. THERE IS NO SURGICAL DELAY. PROCEDURE OUTCOME IS UNKNOWN. NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1) 2.4MM VA LOCKING SCREW STARDRIVE 14MM. THIS REPORT IS 3 OF 10 (B)(4).

  Patient problems: Muscle/Tendon Damage

  MAUDE report 11842160 ↗
• InjurySep 16, 2019Device-Device Incompatibility; Device-Device Incompatibility

  UPDATE: THIS REPORT IS FOR ONE (1) 2.4MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM.

  Patient problems: No Code Available

  MAUDE report 9072293 ↗
• MalfunctionMay 24, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT UPON RECEIVING DELIVERY ON AN UNKNOWN DATE, TWO (2) DRILL BIT WITH DEPTH MARK QUICK COUPLING AND SIX (6) VARIABLE ANGLE LOCKING SCREW WITH STARDRIVE RECESS PACKAGE ARRIVED EMPTY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A 2.4MM VA LOCKING SCREW STARDRIVE 14MM. THIS IS REPORT 7 OF 8 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8642093 ↗
• MalfunctionMay 24, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT UPON RECEIVING DELIVERY ON AN UNKNOWN DATE, TWO (2) DRILL BIT WITH DEPTH MARK QUICK COUPLING AND SIX (6) VARIABLE ANGLE LOCKING SCREW WITH STARDRIVE RECESS PACKAGE ARRIVED EMPTY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A 2.4MM VA LOCKING SCREW STARDRIVE 14MM. THIS IS REPORT 3 OF 8 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8641958 ↗
• InjuryMay 18, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING A DISTAL RADIUS PROCEDURE ON AN UNKNOWN DATE, WHEN THE SURGEON INSERTED A LOCKING SCREW USING A 1.8 THREADED DRILL GUIDE IN THE PROXIMAL PORTION IN THE SHAFT OF A 2.4MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA ¿ LCP) TWO COLUMN VOLAR DISTAL RADIUS PLATE, THE SCREW WOULD NOT LOCK INTO THE PLATE. INSTEAD, THEY USED A 2.4 CORTICAL SCREW. THERE WAS NO OTHER MEDICAL INTERVENTION REQUIRED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THERE WAS A 5-MINUTES DELAY DURING THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE(S): 1.8 THREADED DRILL GUIDE (PART#: UNKNOWN; LOT#: UNKNOWN; QUANTITY: 1) THIS REPORT IS FOR A 2.4MM VA LOCKING SCREW STARDRIVE 14MM THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7526561 ↗
• InjuryMay 18, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING A DISTAL RADIUS PROCEDURE ON AN UNKNOWN DATE, WHEN THE SURGEON INSERTED A LOCKING SCREW USING A 1.8 THREADED DRILL GUIDE IN THE PROXIMAL PORTION IN THE SHAFT OF A 2.4MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA ¿ LCP) TWO COLUMN VOLAR DISTAL RADIUS PLATE, THE SCREW WOULD NOT LOCK INTO THE PLATE. INSTEAD, THEY USED A 2.4 CORTICAL SCREW. THERE WAS NO OTHER MEDICAL INTERVENTION REQUIRED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THERE WAS A 5-MINUTES DELAY DURING THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE(S): 1.8 THREADED DRILL GUIDE (PART#: UNKNOWN; LOT#: UNKNOWN; QUANTITY: 1) THIS REPORT IS FOR A 2.4MM VA-LCP 2-CLMN VLR DSTL RADIUS PL 6H HD/3H SHAFT/LEFT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7526545 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071184, K100776, K102694, K103243. One submission often covers many models, so check the product and lot details in each record.

• Z-0879-2020 · Dec 16, 2019 · Terminated
  2.4MM TI VA LOCKING SCREW STARDRIVE 10MM STERILE, Part Number 04.210.110TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the ste
• Z-0881-2020 · Dec 16, 2019 · Terminated
  2.4MM TI VA LOCKING SCREW STARDRIVE 16MM STERILE, Part Number 04.210.116TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the ste
• Z-0880-2020 · Dec 16, 2019 · Terminated
  2.4MM TI VA LOCKING SCREW STARDRIVE 12MM STERILE, Part Number 04.210.112TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the ste
• Z-0883-2020 · Dec 16, 2019 · Terminated
  2.4MM TI VA LOCKING SCREW STARDRIVE 24MM STERILE, Part Number 04.210.124TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the ste
• Z-0882-2020 · Dec 16, 2019 · Terminated
  2.4MM TI VA LOCKING SCREW STARDRIVE 18MM STERILE, Part Number 04.210.118TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the ste
• Z-2389-2016 · Jun 28, 2016 · Terminated
  Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Plate, Fixation, Bone,
• Z-0323-2016 · Nov 2, 2015 · Terminated
  2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone frag
• Z-2057-2013 · May 31, 2013 · Terminated
  Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting attachment, 1.2Nm Synthes VA-LCP Distal Radius System is intended for fixation of complex intra- and
• Z-0956-2013 · Jan 11, 2013 · Terminated
  Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate, Part Number 02.115.431. Indicated for: Dorsally displaced fractures, Open joint reconstruction, and Cor